|
Trade Name | CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
Medos International, SARL |
chemin-blanc 38 |
le locle 2400 |
|
HDE Number | H060001 |
Supplement Number | S015 |
Date Received | 03/25/2014 |
Decision Date | 11/06/2015 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for design changes to the enterprise®2 vrd and the manufacturing process. |